Catalog Number

-

Brand Name

ProTrach® HME 15 XtraMoist

Version/Model Number

7766

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K151404,K151404

Product Code

JOH

Product Code Name

Tube Tracheostomy And Tube Cuff

Public Device Record Key

f9814203-9945-4d8f-a63d-fc9140dce9d1

Public Version Date

August 23, 2018

Public Version Number

4

DI Record Publish Date

September 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-